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EC number: 947-750-3
CAS number: -
No studies are available for Reaction product of saturated palm
kernel fatty acids and oxybispropanediol. Data were therefore obtained
for the group of polyglyceryl fatty acid esters, the relevant hydrolysis
products and the components in the UVCB substance.
In a two-generation reproduction toxicity study and a prenatal
developmental toxicity study in rats with diacylglycerol oil, rich in
unsaturated fatty acids (>95%),
showed no parental, reproductive and developmental effects up to the
highest dose tested (4,630 mg diacylglycerol/kg bw per day). A NOAEL of
4630 mg diacylglycerol/kg bw per day for reproductive and developmental
toxicity could be derived.
For glycerol (E 422), several prenatal developmental toxicity
studies have been performed with mice, rats and rabbits (EFSA 2017a).
NOAEL of 1280,1600 or 1180 mg glycerol/kg bw per day for mice, rats and
rabbits, respectively, have been derived.
Based on the studies available for the group of polyglycerol fatty
acid esters, the relevant hydrolysis products and the components of the
UVCB substance, it can with a high degree of confidence be concluded
that an assumed NOAEL for "Reaction product of saturated palm kernel
fatty acids and oxybispropanediol" is far above 1000 mg/kg bw/day which
is normally considered as the highest relevant dose level when testing
for reproduction and prenatal developmental toxicity. Thus, "Reaction
product of saturated palm kernel fatty acids and oxybispropanediol" is
not to be classified for reproductive or developmental toxicity.
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